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# TherapeuticsMD Wants Limits on Generic Annovera
- URL: https://www.fdaweb.com/therapeuticsmd-wants-limits-on-generic-annovera/
- Published: 2021-03-16T12:00:00.000Z
- Updated: 2026-09-14T16:50:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148894

In a 3/12 citizen petition, TherapeuticsMD asks FDA not to receive or approve any marketing application that references Annovera (segesterone acetate and ethinyl estradiol vaginal system) unless several specified conditions are met. The [petition](https://downloads.regulations.gov/FDA-2021-P-0293-0001/attachment%5F1.pdf?ref=fdaweb.com) says a marketing application: 

- should only be submitted as an ANDA;
- should cover an ANDA product that is qualitatively and quantitatively the same as Annovera; and
- should cover an ANDA product that has the same macro- and microstructure as Annovera.

“Because Annovera is a complex drug product whose drug release profile is controlled through **(1)** the selection of excipients with specific properties, and **(2)** the manufacturing processes of both the ring body and drug-eluting cores, FDA should also establish appropriate in vitro and in vivo test criteria for the ANDA applicants to demonstrate bioequivalence,” the company says. “Alternatively, the application referencing Annovera as the reference-listed drug should be submitted only under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. To that end, TherapeuticsMD requests that FDA issue product-specific guidance setting forth such requirements.”

The petition says the following quality attributes are important to establishing bioequivalent release of segesterone acetate and ethinyl estradiol over the course of the 13 consecutive 21 days in and seven days out product-use cycles and thus the amount of active ingredient that is available to be absorbed by the patient throughout the course of one year: composition of the vaginal ring system, manufacturing, shape and dimensions, nonlinear release of active ingredients, drug delivery to the vagina -- irritation and toxicity, and instructions for use.